Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001279819
Ethics application status
Approved
Date submitted
11/01/2021
Date registered
22/09/2021
Date last updated
14/11/2022
Date data sharing statement initially provided
22/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of aerobic and resistance exercise on the cognitive function and functionality of individuals with dementia.
Scientific title
Comparative study of different protocols of aerobic and resistance exercise in the context of physiotherapy intervention in the cognitive function and functionality of patients with mild dementia in the community.
Secondary ID [1] 304630 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 320169 0
Depression 322561 0
Condition category
Condition code
Neurological 318109 318109 0 0
Alzheimer's disease
Neurological 318110 318110 0 0
Dementias
Physical Medicine / Rehabilitation 318111 318111 0 0
Physiotherapy
Mental Health 318112 318112 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will include aerobic exercise and resistance exercise. For this purpose, three teams will be created, two (2) intervention and one (1) control. The first intervention group will have a combined aerobic and resistance exercise program and the second resistance exercise only. Programs will be implemented with different duration and frequency for each type of exercise but with moderate intensity for both groups.
The intervention was planned according to studies and guidelines from the American Sports Medicine Association (ACSM) for exercise and prescribing, the American Society of Cardiology (AHA) and in accordance with the recommendations of the World Health Organization (WHO) for physical activity in the elderly.
All participants will be evaluated at the center at the beginning and after the intervention.
During the intervention period, patients in the intervention groups will not be allowed to participate in any other exercise program as well as patients in the control group will not be allowed to participate in any other form of intervention (exercise program) other than that provided in routine care.
The intervention will include:
Intervention group A (Combined aerobic and resistance exercise program)
Aerobic Exercise
The type of aerobic exercise in the present study will involve walking at moderate intensity. The frequency of aerobic exercise will be 5 days a week lasting 30 minutes. Moderate intensity is defined as 64-76% of the HRmax which is the most commonly used indicator for determining the intensity of aerobic exercise. The maximum heart rate is calculated according to the formula: HRmax= 220-age .
Also, the exercise intensity should be verified and the Borg Rating of perceived Exertion (RPE) scale (subjective perception scale of fatigue on exercise) that has been used in studies of people with dementia, as a principal method for estimating exercise intensity during of sessions in combination with indicators such as sweating, skin color, respiratory rate and muscle fatigue. Caregivers will supervise all exercise sessions and physiotherapists once a week for the first 2 weeks and then once a month.
Resistance Exercise
The resistance exercise in the study will concern the main muscle groups of the body and will be performed with free weights at moderate intensity according to 50-69% of a maximum repetition (% 1-RM). The intervention will include 2 sets of 10 exercises with 8-12 repetitions. The frequency of resistance training will be 3 workouts per week (every 48 hours) for 40-45 minutes per session, with a break of 1-3 minutes between sets.
The control of moderate intensity will be monitored based on the scale of subjective perception of fatigue in exercise (RPE) by both the physiotherapist and the caregiver at home.
Intervention group B (Resistance exercise program)
Intervention group B perform the same resistance exercise program as intervention group A.
During the intervention both the aerobic exercise program and the resistance exercise program will be carried out with a gradual increase of the load. Also, both intervention programs will include warm-up and cool-down lasting 5-10 minutes respectively, which will involve active exercises for the head, limbs, torso and stretching.
Caregivers will oversee all exercise sessions at home and physiotherapists will train resistance participants two (2) days out of three (3) at the Alzheimer's Maroussi day center .
The training program and the RPE system were selected and designed so that they can be easily reproduced at home, promote an active lifestyle and after the end of the study.
The schedule must be followed for 12 weeks.
Strategies for monitoring and adhering to the intervention will be one (1) physiotherapist’s visit to the patient's home during the first two (2) weeks and then one (1) visit per month. One (1) phone call once a week for the first month and then one (1) phone call per month. Participants and their caregivers will complete an exercise diary form. The exercise program will also be given in printed form.
Intervention code [1] 319383 0
Treatment: Other
Intervention code [2] 319384 0
Rehabilitation
Intervention code [3] 319386 0
Lifestyle
Comparator / control treatment
No treatment group: Control group participants will be encouraged to maintain their normal daily activities according to their treatment physician guidelines. However, individuals in the group who deviate from their daily routine by following any physical exercise program will be excluded from the study.
Control group
Active

Outcomes
Primary outcome [1] 326129 0
Primary outcome 1: Exercise effect on the general cognitive function of people with mild dementia.
Tools: Addenbrooke’s Cognitive Examination Revised (ACE-R)
Timepoint [1] 326129 0
Timepoint 1: 0 and 3 months after randomization
Primary outcome [2] 326130 0
Primary outcome 2: Exercise effect on the physical function of people with mild dementia.
Tools: Senior Fitness Test (SFT)

Timepoint [2] 326130 0
Timepoint 2: 0 and 3 months after randomization
Primary outcome [3] 328064 0
Primary outcome 3: Exercise effect on instrumental activities of daily living of people with mild dementia.
Tools: Instrumental Activities of Daily Living Scale (IADL)
Timepoint [3] 328064 0
Timepoint 3: 0 and 3 months after randomization
Secondary outcome [1] 390214 0
Secondary outcome 1: Exercise effect on the depression of people with mild dementia.
Tools: Geriatric Depression Scale - GDS -15
Timepoint [1] 390214 0
Timepoint 1: 0 and 3 months after randomization
Secondary outcome [2] 390216 0
Secondary outcome 2: Patients compliance with the exercise protocols.
Tools: Percentage of patients who completed the exercise program by audit of study database
Timepoint [2] 390216 0
Timepoint 2: 3 months after randomization
Secondary outcome [3] 397427 0
Secondary outcome 3: Exercise effect on physical activity of people with mild dementia.
Tools: International Physical Activity Questionnaire (IPAQ)
Timepoint [3] 397427 0
Timepoint 3: 0 and 3 months after randomization
Secondary outcome [4] 397428 0
Secondary outcome 4: Exercise effect on specific cognitive domains (attention processing speed) of people with mild dementia. This outcome is primary (Part of the general cognitive assessment).
Tools: Trail Making Test A
Timepoint [4] 397428 0
Timepoint 4: 0 and 3 months after randomization
Secondary outcome [5] 397429 0
Secondary outcome 5: Exercise effect on specific cognitive domains (executive functions) of people with mild dementia. This outcome is primary (Part of the general cognitive assessment). Tools: Trail Making Test B
Timepoint [5] 397429 0
Timepoint 5: 0 and 3 months after randomization
Secondary outcome [6] 397430 0
Secondary outcome 6: Exercise effect on specific cognitive domains (attention) of people with mild dementia. This outcome is primary (Part of the general cognitive assessment).
Tools: Digit Span forward Test
Timepoint [6] 397430 0
Timepoint 6: 0 and 3 months after randomization
Secondary outcome [7] 397431 0
Secondary outcome 7: Exercise effect on specific cognitive domains (working memory) of people with mild dementia. This outcome is primary (Part of the general cognitive assessment). Tools: Digit Span backward Test
Timepoint [7] 397431 0
Timepoint 7: 0 and 3 months after randomization
Secondary outcome [8] 397432 0
Secondary outcome 8: Exercise effect on balance of people with mild dementia. This outcome is primary (Part of the general physical function assessment) Tools: Berg Balance Scale (BBS)
Timepoint [8] 397432 0
Timepoint 8: 0 and 3 months after randomization
Secondary outcome [9] 401198 0
Primary outcome 9: Exercise effect on the general cognitive function of people with mild dementia. This outcome is primary.
Tools: Mini Mental State Examination (MMSE)
Timepoint [9] 401198 0
Timepoint 9: 0 and 3 months after randomization

Eligibility
Key inclusion criteria
Inclusion criteria: a) age 65 years and older b) diagnosis of mild Alzheimer’s dementia, as determined by the treating physician c) Mini-Mental State Examination (MMSE): 20-24/30 d) ability to move to the intervention place e) existence of a caregiver f) sufficient hearing and vision g) medical consent to participate in the exercise h) absence of any other exercise program i) without medication change for at least 2 months j) ability of consent k) have already been considered as capable for consent from the treating physician and the treatment team.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria: a) other dementia type b) neurological disease with severe motor and cognitive problems c) serious diseases where is inappropriate participation in exercise, in consultation with the treating physician such as severe psychiatric illnesses, uncontrolled blood pressure severe cardiorespiratory problems, severe musculoskeletal problems d) malignancy e) recent surgery (<12 months) f) severe vision/hearing problems g) alcoholism h) drug use

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/10/2021
Actual
4/10/2021
Date of last participant enrolment
Anticipated
14/11/2022
Actual
Date of last data collection
Anticipated
6/02/2023
Actual
Sample size
Target
120
Accrual to date
118
Final
Recruitment outside Australia
Country [1] 23358 0
Greece
State/province [1] 23358 0
Athens

Funding & Sponsors
Funding source category [1] 307489 0
Self funded/Unfunded
Name [1] 307489 0
Country [1] 307489 0
Primary sponsor type
Individual
Name
Vasileios Papatsimpas
Address
General Hospital of Athens: G. Gennimatas
Avenue Mesogeion 154. Athens 11527
Greece
Country
Greece
Secondary sponsor category [1] 309928 0
Individual
Name [1] 309928 0
Daphne Bakalidou
Address [1] 309928 0
University
University of West Attica. Physiotherapy Department.
Agiou Spyridonos 28. 12243 Egaleo – Athens
Greece
Country [1] 309928 0
Greece
Other collaborator category [1] 281586 0
Other Collaborative groups
Name [1] 281586 0
Athens Alzheimer's Disease Company
Address [1] 281586 0
M. Mousourou 89 & Stilponos 33, 116 36 Athens
Country [1] 281586 0
Greece
Other collaborator category [2] 281587 0
Hospital
Name [2] 281587 0
General Hospital of Athens: G. Gennimatas
Address [2] 281587 0
Avenue Mesogeion 154, Athens 115 27
Country [2] 281587 0
Greece

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307564 0
The Committee for Ethics of the University of West Attica
Ethics committee address [1] 307564 0
University of West Attica
Agiou Spyridonos 28, 12243 Egaleo - Athens
Ethics committee country [1] 307564 0
Greece
Date submitted for ethics approval [1] 307564 0
Approval date [1] 307564 0
25/11/2020
Ethics approval number [1] 307564 0

Summary
Brief summary
Dementia is a clinical syndrome characterized by impaired cognitive functions and gradual deterioration of physical function. The objective of this study is to investigate the effect of exercise on cognitive and physical function in patients with Alzheimer’s disease and provide information on the appropriate types of exercise and its parameters to maintain and improve cognitive and physical function. The main study hypothesis is that exercise has an effect on cognitive and physical function of patients and that different exercise protocols have different effect size on cognitive and physical function. It is a randomized control trial. The intervention will include aerobic exercise and resistance exercise and three groups of patients: two intervention groups and one control group. The first intervention group will follow a combined aerobic and resistance exercise program and the second group resistance exercise only. Participants in the control group will continue their usual routine. The results are expected to further facilitate the design of individualized exercise programs for elderly with dementia in the community aiming at functionality improvement.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 107690 0
Mr Vasileios Papatsimpas
Address 107690 0
Hospital
General Hospital of Athens: G. Gennimatas
Avenue Mesogeion 154. Athens 11527
Greece
Country 107690 0
Greece
Phone 107690 0
+306974580260
Fax 107690 0
Email 107690 0
[email protected]
Contact person for public queries
Name 107691 0
Mr Vasileios Papatsimpas
Address 107691 0
Hospital
General Hospital of Athens: G. Gennimatas
Avenue Mesogeion 154. Athens 11527
Greece
Country 107691 0
Greece
Phone 107691 0
+306974580260
Fax 107691 0
Email 107691 0
[email protected]
Contact person for scientific queries
Name 107692 0
A/Prof Daphne Bakalidou
Address 107692 0
University
University of West Attica. Physiotherapy Department.
Agiou Spyridonos 28. 12243 Egaleo – Athens
Greece
Country 107692 0
Greece
Phone 107692 0
+306977691276
Fax 107692 0
Email 107692 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.